Ruxolitinib cream approved for the short-term treatment of atopic dermatitis
The first topical Janus kinase inhibitor (JAK) cream for the treatment of atopic dermatitis (AD) was approved this week by the FDA.
Ruxolitinib cream, which will be sold as Opzelura, has been approved for the short-term, non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 12 years of age and older with no disease. not adequately controlled by prescription topical treatments, or when such treatments are not advised.
AD is a chronic skin disease affecting more than 21 million people aged 12 and over in the United States and is characterized by inflammation and itching. Signs and symptoms include irritated and itchy skin that can cause red lesions that can ooze and scab. Patients are also more susceptible to bacterial, viral and fungal infections.
FDA approval was based on data from the Topical Ruxolitinib Evaluation in Atopic Dermatitis (TRuE-AD) clinical trial program, consisting of 2 randomized, double-blind, vehicle-controlled rhase 3 studies (TRuE-AD1 and TRuE-AD 2) evaluating the safety and efficacy of the cream in over 1200 adolescents and adults with mild to moderate AD.
Patients experienced a significantly sharper reduction in skin and itching when treated with a medicated 1.5% twice daily (BID) cream, compared to a non-medicated cream.
In addition, a significantly higher number of patients treated with ruxolitinib cream achieved the Investigator’s Global Assessment (IGA) Treatment Success (IGA-TS; primary endpoint) at week 8 (defined as an IGA score of 0 [clear] or 1 [almost clear] with an improvement of at least 2 points compared to baseline): 53.8% in TRuE-AD1 and 51.3% in TRuE-AD2, compared to non-drug treatment (15.1% in TRuE-AD1 , 7.6% in TRuE-AD2; P <.0001>
A significantly higher number of patients treated with ruxolitinib cream had a clinically significant reduction in itching compared to baseline at week 8, measured by a reduction of at least 4 points on the numerical rating scale itching (NRS4 itch): 52.2% in TRuE-AD1 and 50.7% in TRuE-AD2, compared to non-drug cream (15.4% in TRuE-AD1, 16.3% in TRuE-AD2 ; P <.0001 among patients with an nrs score of at least baseline.>
As with some other drugs in the class, ruxolitinib cream has boxed warnings for serious infections, mortality, cancer, major adverse cardiovascular events, and thrombosis.
“Atopic dermatitis is a chronic immune-mediated disease that can be difficult to manage. Many patients do not respond well to existing treatments and have uncontrolled disease, ”said Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology and director of clinical and contact dermatitis research at George Washington University. School of Medicine and Health Sciences, in a statement.
“It can be difficult for people to fully appreciate how difficult AD can be and the enormous impact it has on patients,” added Julie Block, President and CEO of the National Eczema Association. . “Chronic itching is difficult to manage and the associated sleep problems can be exhausting. Many patients and their dermatologists are looking for additional options to address current unmet needs in the management of AD.
In clinical trials, the most common treatment-related side effects in patients treated with ruxolitinib cream were nasopharyngitis, diarrhea, bronchitis, ear infection, increased number of eosinophils, urticaria , folliculitis, tonsillitis and rhinorrhea.